Good morning. Thanks for joining us. I'm Bob Fenton, the White House Monkeypox Response Coordinator. Today, I'm joined by Dr. Fauci, Dr. Walensky, and Dr. Daskalakis. Before I turn to my colleagues, I want to provide an update on the important progress we're making in combatting monkeypox. We continue to leverage every capability at our disposal and partner with leaders on the ground to meet people where they are with vaccines, tests, treatments, and information. Over the last couple of weeks, our large event pilot has been incredibly successful: Over 3,300 shots were administered at Southern Decadence in New Orleans, over 1,000 shots were administered at Oakland Pride, and over 4,000 shots were administered at Black Pride in Atlanta. And we recently were notified that Charlotte administered an additional 1,500 doses in the days and events following Charlotte Pride last month, bringing the total vaccine administration as part of the pilot program to nearly 11,000 doses. Importantly, these efforts are reaching Black and brown communities, a top priority of this administration. By vaccinating thousands of people at high risk who might not otherwise have gotten a shot, this program is working to advance equity and combat this outbreak. We continue to build on this work by making additional vaccines available for large and small equity interventions across the country, which Dr. Daskalakis will talk about more. Stepping back, we're seeing the impact of this admin- -- of the administration's comprehensive strategy to fight monkeypox in the latest case trends and other promising data points. Overall, new case numbers are down nearly 50 percent since early August. And in places like Atlanta, where we've worked closely with the public health community to surge vaccines and the information around events like Black Pride, the rate of new cases has been steadily declined. And in D.C., the new cases have declined 20 percent on average per week since a peak in mid-July. And knowledge of our tools and interests in using them has increased. According to research released today from the University of Pennsylvania, knowledge of a monkeypox vaccine has jumped from approximately a third of Americans to over 60 percent. More than two thirds of Americans understand the risk profile and behaviors for monkeypox. And nearly three quarters of Americans said they would get vaccinated if exposed to monkeypox. What this shows us is that our work to expand knowledge of monkeypox and our tools to fight it, alongside so many local health departments and other community organizations, is working. We know there's a lot more to do, especially for Black and brown communities where the burden remains high. But there's no question that the work we've done to rapidly increase vaccine supply, get people vaccinated, [DEL: wrap :DEL] [ramp] up the availability of testing and treatments, and educate individuals on how they can protect themselves is making a tremendous difference. The administration's strategy is working. And as you'll hear from Dr. Fauci and Dr. Daskalakis, we'll continue to work nonstop to get more shots in arms, more information out to the highest-risk individuals, and learn as much as we can about this virus and our treatments so we can quickly and effectively end this outbreak. With that, let me turn to Dr. Fauci, who will talk about clinical trials recently launched to make sure we can effectively treat those who have con- -- contracted the virus. [Inaudible] minutes talking to you about what Bob mentioned, but also giving somewhat of a brief overview -- if I could have the first slide -- of the NIAID research priorities for monkeypox, which generally and broadly fall under five major pillars. There are a number of unanswered questions. So as we implement the interventions that we have, simultaneously, we still pursue some unanswered questions. Namely, addressing gaps in basic virology and immunology and immune correlates; understanding better transmission, as well as the issue of animal reservoirs not only potentially here in the United States, but also globally. Also, the importance of developing newer diagnostics and assays, particularly diagnostics to be able to determine if we can see if a person in the asymptomatic or pre-symptomatic stage that doesn't have an obvious lesion -- is there some diagnostic test that we can do to alert us to that and therefore help stop the spread. Also, to evaluate new treatments -- I'm going to speak about one of the treatments that we have and how we're improving our knowledge of that, but also the development of other antiviral drugs. And then finally and importantly, to optimize and advance our vaccine regimens. Next slide. What I'm going to mention in the next couple of minutes are two significant clinical trials. One in the therapeutics for tecovirimat or TPOXX. And there are actually two trials within that category: one here in the United States and one internationally. And then also to take a look at the vaccine studies that we're doing for JYNNEOS. If I could have the next slide. In the United States, we are conducting -- and it has already started on September the 8th -- a phase three trial of tecovirimat for monkeypox in the United States. That is referred to as the STOMP trial, standing for: the study of tecovirimat for human monkeypox virus. As you know, the TPOXX is approved for smallpox by the animal rule. But for monkeypox, it still is under an expanded-access IND. So the plan will involve more than 60 clinical sites in the United States with a target enrollment of 530 people. We're going to randomize people -- two to one -- to receive TPOXX versus placebo. A very important aspect of this that we learned from our experience back in the days of HIV is to get the community involved in being able to determine what is best for them. So in the trial, there is an open-label segment, which will enroll children; people at risk, such as pregnant individuals, breastfeeding individuals; and others with severe disease. So if a person comes in and has severity of disease, they can be in the trial, but they will be in an open-label component, which means they will receive TPOXX. And again, more information about this trial is shown on the link on the slide. Next slide. In addition to that, we're doing a phase three trial of tecovirimat for monkeypox in the Democratic Republic of the Congo. Recall that when you look at the different clades, the Congo clade is Clade one, which has a higher degree of mortality that they've experienced with that, compared to the very low degree of mortality in the Clade twos that are currently in the United States. This trial, again, is a randomized, double-blind, placebo-controlled trial that will open imminently. It's co-led both by the NIAID as well as the Democratic Republic of the Congo's National Institute for Biomedical Research. Again, the target is 450 adults and children -- weight three kilograms or more -- with laboratory-confirmed infection. Pregnant women are eligible in this particular study because of the risk that is ongoing and, actually, practical now in the DRC. In that study, the participants will be randomized one to one and assigned to either receive TPOXX or a placebo for the two times a day for 14 days. Given the severity of the disease in the DRC, all participants will remain in the hospital until recovery. Next slide. And finally, a trial for JYNNEOS, or monkeypox vaccine. Now, monkeypox and smallpox are given subcutaneously. And that, in fact, has been approved by the FDA, but the intradermal administration is now still an EUA. Again, this trial opened on September the 8th. The target is 200 individuals from 18 to 50, across eight United States sites. Now, the participants are going to be assigned at random to one of three study arms: either the standard licensed regimen of JYNNEOS administered subcutaneously, but there will be two separate doses -- a 1 to 5 of the standard dose intradermal, that's the one that was recently authorized by the FDA; and then 1 to 10 of standard dose administered intradermally. The 1 to 10 is to determine -- because in the United States, we have enough doses to handle the people who are at risk, but this is a global problem, and we're going to make a contribution -- if, in fact, 1 to 10 works, that will immediately double the amount of doses available on an international scale. And we're going to determine whether the peak responses induced in the recipients intradermally are as least as good as the responses introduced with regard to the licensed subcutaneous regimen. Also, there will be additional data on the relative safety and tolerability of the regimens. And then finally, more information on these trials can be seen on ClinicalTrials.gov. With that, I'll hand it over to Dr. Walensky. Thank you, Dr. Fauci, and good morning. Today I'd like to share with you the latest data out of CDC on the current monkeypox outbreak. As of September 14th, over 59,600 cases have been detected globally in 103 countries. In the United States, there have been nearly 23,000 cases of monkeypox identified across all 50 states, the District of Columbia, and Puerto Rico. Over the last several weeks, we've been pleased to see a decline in the growth of new cases here and abroad, though there are areas of the U.S. where the rate of rise in new cases is still increasing. We approach this news with cautious optimism. It is a result of education efforts, the work being done to vaccinate at-risk individuals, and people who have made informed decisions to make temporary changes to their behavior to protect themselves and their communities. We recognize, however, that we must continue to aggressively respond with our entire toolkit. Over the past several weeks, we have also seen the racial and ethnic makeup of this outbreak evolve. While monkeypox cases were first seen predominantly in non-Hispanic white men, in the last week, among the cases for which we have race and ethnicity data, non-Hispanic men represented 38 -- non-Hispanic Black men represented 38 percent of cases, Latino or Hispanic men represented 25 percent of cases, and non-Hispanic white men represented 26 percent of cases. We continue to closely monitor data on this outbreak, those at risk, and how prevention measures are being used. Yesterday, CDC posted new JYNNEOS vaccine administration data by jurisdiction. In addition to reporting aggregate vaccine administration data by total number, age, sex, race, and ethnicity, these newly available data displayed total doses administered for each of the individual 39 jurisdictions for which we have received data. We continue to work closely with additional jurisdictions to make their data available in this report. To date, over 540,000 doses of vaccine have been administered across the 39 jurisdictions reporting data. Over the past few weeks, we've seen an increase in second doses administered as more people have become eligible for their second dose, specifically 28 days after their first dose. As a reminder, JYNNEOS is a two-dose vaccine and it is important to receive the second dose in the series to have the best protection against monkeypox, which current data suggest occurs 14 days after that second dose. Working closely with jurisdictions to provide the most complete picture of who is getting vaccinated, we've been able to receive data on race and ethnicity for over 91 percent of the first doses reported. Among these first doses reported, those who are white represent about 47 percent of people who received their first dose. Those who are Hispanic represent about 21 percent. And those who are Black represent about 12 percent. Given the data that I shared early on case demographics, the percentage of vaccines administered to Latinos or Hispanic men and non-Hispanic Black men are disproportionately lower than we are seeing represented in cases. It is critical that education, vaccinations, testing, and treatment are equally accessible to all populations, but especially those most affected by the most -- most affected by this outbreak. CDC remains committed to collaborating with jurisdictions to reduce health disparities. In an effort to allocate monkeypox vaccines more equitably, to reduce racial and ethnic disparities in vaccinations, and to overcome systemic and structural barriers, the U.S. government launched two pilot proj- -- programs to provide vaccines to populations at risk, which Dr. Daskalakis will outline in more detail. We've already had success with this approach with the pilot program for vaccination at large gatherings that was announced on August 18th. So far, through this program, monkeypox vaccines have been administered to over 10,000 people at large events, including Southern Decadence in New Orleans, Atlanta Black Gay Pride, Charlotte Pride, Boise Pride Festival, and Oakland Pride and Pridefest. This new Monkeypox Vaccine Equity Pilot Program will help expand these efforts to engage with communities in smaller events and interventions focused on addressing disparities. The application process for the program is open and available on CDC's website, and Dr. Daskalakis will also speak to this in further de- -- in detail. At CDC, we continue to prioritize health equity in all of the work that we do. And I am very proud of the work to launch this new vaccine equity program and the opportunities for equity it presents. Thank you, and I will now turn it over to Dr. Daskalakis. Thank you, Dr. Walensky. As Dr. Walensky and Mr. Fenton mentioned, we're seeing encouraging signs in our fight against this monkeypox outbreak, with cases regularly trending down -- in fact, down by nearly 50 percent since its peak in early August. While there is more work we're doing to reach all of the community at highest risk, I want to be clear: This is the result of our hard work together to increase the availability and use of testing, make vaccines readily available to the people who could benefit most, providing guidance on how to avoid monkeypox through changing behaviors. And the community has done it. But, as you're hearing, our work is far from over. As we've said, equity must remain the cornerstone of our response. And currently, some jurisdictions are still seeing increasing rates of monkeypox infections while others are seeing a decline. We're also seeing that monkeypox cases are concentrating in gay, bisexual, and other men who sex with men of color while, as you heard, most vaccines have been administered to white men. Early adopters, as we see in the data, have begun or completed their vaccination series. We are now entering the harder phase of the vaccination campaign, where we need to work to make sure that we continue to get first doses into arms and ease access for second doses. That means we need to use hyperlocal strategies that let us reach deeper into the community. The large-scale interventions we launched focusing on events have resulted in over 11,000 doses of vaccine getting into the arms of people who might not have sought services in more traditional places. Sixty-three percent of vaccines allocated for these events have gone into arms. In Georgia, nearly 70 percent of the people who were vaccinated at Black Pride identified as non-white. Nearly 50 percent of the vaccines administered there were to Black people. These interventions are working and, as you heard, we have more coming. As I've said before, these large-scale events are one lever, but we know that sustained community outreach will make the difference. That's why today, as you heard, we're opening applications for our second equity intervention pilot that focuses on smaller projects that help us reach the communities we need to link to monkeypox vaccines, education, testing, and treatment. Health departments will use their local experience and connection to the community to identify hyperlocal strategies to improve vaccine access to communities of color, specifically those that are overrepresented in this outbreak. CDC will provide them with vaccine, materials, and the technical assistance needed to realize these local interventions. And it will help us learn what works to get needed monkeypox vaccine and services to populations. We have allocated 10,000 vials -- that's up to 50,000 doses of vaccine -- for these smaller equity interventions. And as Dr. Walensky said, the application is going to be available on CDC's website. And the administration will be promoting this new pilot program through direct communication with public health community partners, as well as through social media. Our data tells us that monkeypox is not an infection that exists in isolation. It travels with HIV and other sexually transmitted infections. An MMWR published last week tells us that 61 percent of people diagnosed with monkeypox either had HIV or an STI. We quickly used this data to change how monkeypox services can be supported by public health departments, clinics, and community-based organizations Last week, CDC communicated to these funded health departments and directly funded HIV prevention community-based organizations that their HIV and STD staff and dollars could be used to help us end the monkeypox outbreak. The same people we need to test for HIV and sexually transmitted infections and lead to prevention and care are the same people who need monkeypox-related services like testing, education, and vaccines. This important change in guidance to recipients of these funds allows our frontline health departments and community-based organizations to use their HIV and STD resources to accelerate us all to the end of the monkeypox outbreak and will also help us do better HIV and STD prevention for the exact same population. This is just the latest example of us being responsive to what's happening on the ground and pivoting our focus and our resources where they're needed most. Thank you. Well, thanks, Doctors. Kevin, let's open it for questions. A few questions. First, let's go to Issam Ahmed at AFP. Yeah, thanks for doing this and for taking my question. Perhaps for Dr. Walensky: Obviously, the trends nationally look good. Where do you sort of -- what do you attribute for that? Is it the vaccine campaign paying off mostly? Or -- and how confident are you that that it'll keep falling and we're not going to see a rebound? And then, just, I guess, as a secondary to that is: What's your concern level of it spilling into wider populations, such as pediatric? Thank you. Yeah, thank you for that question. I think, first, we should note that we have made strong progress, and we're encouraged by the cases -- the case rate of rise declining. And yet we are keeping our -- the gas pedal heavily, heavily downward -- pedal to the metal -- as we continue our activities to -- and we continue the vigilance here. What do I attribute it to? I attribute it to the multi-layered approach of all the things that we're doing: the testing that we scaled up, the massive amounts of education and outreach, the vaccinations that we've been able to get out. And still, as Dr. Daskalakis noted, we're working to get to harder-to-reach communities, to communities that might not have been first in line, but might have been slower to uptake. And that's exactly where we are right now with all of -- all of these pilot activities. Let me have Dr. Daskalakis add also to that question. Yeah, so I'll just say, again, this is a toolkit and you have to use every tool in the toolkit, which is the lesson that we've learned from so many other infections, including HIV. So I think that, again, the behavior change, the vaccine, the testing, the messaging, and the equity focus are all strategies that are going to lead us to control of this outbreak. I'll also address the question about spread to other populations. So we have vigilance for that with our surveillance, and I think CDC can speak to that and Dr. Walensky can speak to that. But I'll also say that what we're seeing is really terminal chains in those populations. It's not a really eff- -- efficient group through which this is transmitting. So, knowledge is important; anxiety is not. So the awareness is what matters. Let's go back to Dr. Walensky. Yeah, if I could just -- yeah, thank you. Yeah. Yeah, thank you. Sorry to miss that second part of the question. Dr. Daskalakis is exactly right. We've done extraordinary outreach to providers in those educations. We've had guidance and calls with K though 12 educators, with university presidents, health educators to really make sure that they know what they're looking for should a patient come in. But again, as Dr. Daskalakis noted, we've really seen terminal chains. If and should there be a single case, we generally don't see extension of those cases in those settings. Thank you. Kevin, we'll take another question. We'll go to Madison Muller at Bloomberg. Hi, thanks for taking my question. You know, you said that you are keeping the gas on the pedal and really, you know, honing in on ensuring that the infections continue to go down. And so, I'm sort of wondering like what the strategy is now going forward. I know that you're focusing on equity, but also just, you know, what are the things that you're doing to ensure that there's no complacency and that, you know, we continue to drive these cases down? Yeah, I think -- this is Bob. So, it's all the above. It's all the tools that Dr. Daskalakis briefed going forward. It's continuing to make sure that -- you know, that we ensure that vaccine uptake continues to improve, and we continue to work to vaccinate especially those that are that are the hardest to reach and really bring vaccine to them through some of these interventions. But let me turn to Dr. Walensky first and then Dr. Daskalakis to speak in some more detail about some of those efforts. Yeah, I mean, a lot of this is -- in addition to vaccination and providing those vaccines, it's the education. At every single one of these large events, there's been a massive amount of resources, education, folks on the ground teaching people in the community what to look out for, how they can protect themselves, what behaviors might lead to more infection, what behaviors -- how they might change their behavior to lead to less infections. And the more and more we do that, the more that knowledge increases. When we have that knowledge increase, as Mr. Fenton just noted, we see that communities understand. They understand how to protect themselves, they understand the behaviors that increase risk, they understand how vaccination could decrease risk. So, it is it is outreach to both providers, clinicians, so they know what they're looking for, and to the community. Dr. Daskalakis? So, I'll start by saying what's exciting is that the administration's strategy here is working. And I think Dr. Walensky and Mr. Fenton have been clear that it's about education, about testing, about treatment, and about vaccine. So, you don't use just one tool in the toolkit to build a house; you use all the tools. And so, we're really using all of them together. And I think we have some really positive news from that study from the University of Pennsylvania that says that our messaging is coming through, and also some cautiously optimistic but good news from the perspective of what we're actually seeing with numbers in the outbreak. Now we really have the hard part of the job to do, which is the early adopters have listened, we really need to hunker down and get deeper into the community as we're doing with these two equity pilots and all of the amazing work jurisdictions are doing on their own outside of his equity pilots. Bob, I might just mention one other thing I think is important, because we keep talking about the lessons that we've learned from HIV that are positive lessons. Back in the day when we were seeing patients -- literally in the '80s, when we were telling physicians to ask questions of patients that they would not have asked before, like uncomfortable questions about sexual activities, which really got diagnostics, really, right up there. So, as Dr. Walensky and Dr. Daskalakis said, when you go out to the providers and tell them to be alert for things that they may not have otherwise looked for, that's a very good way to answer the question that was just asked about how do you make sure with surveillance that you pick up things that might be in the community that you didn't see before. It's a very important lesson that we learned from HIV. I just want to add one more thing, because I -- it's really important to say we're not the only ones who have our foot on the gas pedal. The community has their foot on the gas pedal too. And they're really helping us, both from the perspective of addressing the outbreak and they will also help us from the perspective of getting the research done that we need so that we understand how to use TPOXX and vaccine in the best possible way. So it's an all-of-society effort, not just government, and really kudos and cheers to the community for putting their foot on that pedal. They've been invaluable partners. Thanks, Doctors, for all those responses. Let's, Kevin, go to another question. Of course. Chris Johnson, Washington Blade. Hi, thanks for taking this call. You talked a lot about in the -- in this call how, on one hand, equity has been a primary focus of the administration's efforts on the monkeypox outbreak. But at the same time, we're seeing numbers where the new cases are shifting increasingly among men of color. Why do you think these efforts for increased -- for equity are not having an effect of producing equity in the cases? Yeah, let me start with Dr. Walensky, and then we'll go from there. Yeah, I mean, this is not uncommon for many infectious diseases, quite unfortunately. And it is why before we even saw those shifts, we embarked on these activities because we anticipated that this might be happening. And it is exactly for these reasons why we started on these pilot projects before we even saw the shifts in data, is that is often the case in infectious diseases that we have more vulnerable population -- racial and ethnic minorities -- who are most impacted later on. And so, we anticipated in this. We have embarked on these activities to address this in exactly this moment. I'll just add, I've spoken to providers on the ground and also promoters at these events who have really noted that this effort is really unprecedented in terms of reaching deeply into these communities. And so, I think, as CD- -- as Dr. Walensky says for CDC, I think all of our commitment in the administration is to really focus efforts on equity to resolve the issues that we're seeing. It is a hard effort and it's a challenge. And I think that the way to address equity is intentionally, and this is an example of intentional work to address equity. Kevin, can you see if we can have another question? Pien Huang at NPR. Hey, thanks for taking my question. I have a question on the research. So, Dr. Fauci, you listed five research priorities that then focused on vaccines and treatments. And so I just want to know: Are there other trials that are planned to understand basic virology transmission? Is there funding available to sort of pursue this full research agenda? Well, there's two parts to your question. When you talk about the other basic questions that I asked, they are not yet at the level of clinical trial. What we will be doing is developing the tools that will ultimately get translated into an implementable clinical trial. But for example, when you're talking about fundamental, basic virology and immunology, we're going to be doing a number of things. For example, in the TPOXX study, we're going to be looking for resistance to TPOXX, which is really very important. We're going to be looking at immune correlates. Those are the things that we are going to be doing. The clinical trials that I mentioned are the ones that are ongoing. But as you know, there's a continuum from preclinical to early clinical to advanced development. In those other questions, we are still at the level, for example, when you screen for new drugs, you develop assays looking at the replication cycle of the virus, which, fortunately for us, we have decades of experience with pox viruses, and we'll utilize that to develop vulnerable targets to be able to use molecules that are already existing to develop them or to development of brand new molecules aimed at that. With regard to the financing, I mean, obviously, as we've said many times, I have had to move money from other areas to be able to address the questions that I mentioned to you before. The money that we're using on the clinical trials is money that we've taken from our poxvirus portfolio, as well as others. So we hope that we get supplemental funding to be able to do the things that I'm talking about. Thank you. Kevin, another question, please. Couple more questions. Let's go to Krista Mahr from Politico. Thanks so much. One follow-up question for Dr. Fauci regarding what you just said and what Dr. Califf said yesterday at a HELP hearing. That's twice I've heard the administration mention concerns over resistance to TPOXX in the past couple of days. Is this just like a theoretical concern or is this something that there's some evidence of happening? Second question is: I understand that second doses are up in the latest tranche of vaccination data, but first doses are really dramatically down. And I'm just wondering if you guys have any sort of on-the-ground feedback about why that is happening, kind of, from physicians, from community workers. Is there, you know, a feeling that, as cases go down, people just don't feel like they -- the urgency is gone? Is there concerns about the intradermal dosing? Those are my questions. Thanks. Yeah, let's start with CDC and Dr. Walensky. So to address that second question, maybe -- I will just say: This happens, you know, when we rolled out other vaccines as well. We see the initial people who are -- have rolled up their sleeves before they've reached the pharmacy. They're really anxious to get this. And then we see a waning off of interest in vaccines. And that's where, as Dr. Daskalakis said, is the hard work. That's where we need to do the outreach. We've become accustomed to doing that outreach. We've learned some lessons from how we've done it during COVID, of course. And we're taking those lessons learned and doing that hard work of community outreach. We've seen successes through doing so. We've seen them in these large equity events, in these large gay Pride events. And now we will do -- continue to do the hard work and reach the smaller events as well. With regard to the first question about resistance, whenever you have a viral illness that spread with replication largely in the community and you have a single drug that you're using, there is always the theoretical possibility of resistance. And that's the reason why we're uncomfortable when you only have a single drug that has been shown to have efficacy -- or you're proving that it has efficacy, which is part of the clinical trial. That's the reason why we're putting an effort on looking at other targets in the replication cycle. Let me see if Dr. Daskalakis wants to add anything to the discussion. Just one thing to add, which is that, again, that recent announcement from CDC about flexibility in using HIV, STD resources to be able to address monkeypox is a really important lesson that monkeypox is not a disease that we're working with in isolation. So as we continue to do the important HIV, STD work, it's blending with the monkeypox work, and vice versa. So this is all part of a strategy to make sure that we're able to reach deeper in the community, whether it's large equity events, smaller equity interventions, or using infrastructure with demonstrated effectiveness to reach people. All of that is in the mix to make sure that we get education to people, testing to people, and vaccines in people's arms. Thanks. And maybe if I might just add: Our local jurisdictions have received no resources specific for monkeypox. So not only have we had to move some of those resources around, but they've been pretty stretched -- they've been stretched pretty thin with regard to the resources that have been available to them to address this outbreak. And so, first of all, kudos to them for all that they've been able to do and achieve on limited resources. And again, it speaks to the need for supplemental funds. With that, I just want to end with summarizing: This administration has made tremendous progress toward the fight against monkeypox, and we'll continue to use every tool to do that. With that, thank you today for your questions and have a good day.